Alternative anti-tuberculosis regimen including ofloxacin for the treatment of patients with hepatic injury.

SETTING: Tuberculosis (TB) clinic of a university-based public hospital in Rio de Janeiro city, Brazil.

OBJECTIVE: To describe treatment outcomes for TB patients with liver injury who received a 12-month regimen of ethambutol (E, EMB) and ofloxacin (O, OFL), including streptomycin (S, SM) for the first 3 months (3SEO/9EO) under routine clinical care conditions.

DESIGN: A retrospective study of a cohort of TB patients prescribed 3SEO/9EO was conducted over a 66-month period. Data were obtained by review of existing medical records. Primary outcomes assessed were cure, treatment failure, treatment default, TB relapse and death.

RESULTS: Outcomes were assessed for 40 patients with hepatic injury who met study criteria. Twenty-three (58%) were male and 13 (33%) were human immunodeficiency virus seropositive. Thirty-four (85%) patients were cured. Three patients (7.5%) defaulted from treatment, and three other patients died (7.5%). There were no treatment failures or relapses during 2 years of follow-up. Clinically recognized drug toxicity occurred in five patients (12.5%), and in each case was attributed to SM.

CONCLUSION: In this series of TB patients with serious liver injury, 3SEO/9EO was well-tolerated, and it was effective in 85% of patients when used under routine clinical care conditions.